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Senior Manager, Regulatory Operations

Prime Medicine· Regulatory Affairs
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Cambridge, MA$149k - $166kFull-timePosted 1w ago

About the role

Senior Manager, Regulatory Operations plans, coordinates, and drives regulatory submissions and program timelines across Prime Medicine’s product pipeline, partnering with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality to ensure complete, high-quality, on-schedule submissions to global health authorities.

Responsibilities

  • Submission Planning & Execution: Lead end-to-end planning and execution of regulatory submissions, including INDs/CTAs, BLAs/MAAs, amendments, annual reports, and briefing packages.
  • Timeline & Risk Management: Develop and maintain integrated regulatory timelines, track milestones and dependencies, identify critical-path risks, and drive mitigation plans.
  • Cross-Functional Coordination: Partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners to compile, quality-check, and finalize submission content.
  • Health Authority Interactions: Support preparation for health authority meetings, including briefing books, logistics, meeting minutes, and action item tracking.
  • Information Requests: Track incoming health authority information requests (IRs) and coordinate timely, well-organized responses across functional teams.
  • Document & Systems Management: Manage regulatory publishing and document management systems, ensuring submissions meet eCTD and other applicable technical standards.
  • Process & Compliance: Maintain regulatory operations SOPs and tracking systems; identify and implement process improvements to increase efficiency and quality.
  • Vendor & Budget Oversight: Support management of regulatory operations vendors and budget, including publishing and translation vendors.

Qualifications

  • Bachelor's degree in life sciences, regulatory affairs, or a related field.
  • 7+ years of experience in regulatory affairs or regulatory operations within the pharmaceutical or biotechnology industry.
  • Demonstrated experience managing IND/CTA and BLA/MAA submissions from planning through filing.
  • Strong working knowledge of eCTD structure, regulatory publishing tools, and document management systems (e.g., Veeva Vault RIM or similar).
  • Proven project management skills, with the ability to manage multiple concurrent programs and competing priorities.
  • Excellent written and verbal communication skills, with strong cross-functional collaboration and stakeholder management abilities.
  • High attention to detail and a strong quality mindset.

Skills

Required:Regulatory submissions managementProject managementeCTD and regulatory publishingCross-functional collaboration

Benefits

  • Total Rewards package with health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.
Last updated Oct 14, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
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